Vascular Closure Devices — One More Truth to Immediate Closure

Vascular closure devices (VCDs) provide simple, painless and reliable hemostasis following endovascular procedures performed via femoral arterial access. Their use has enhanced patient comfort and satisfaction, shortened the time to ambulation and preserved valuable catheterization laboratory resources.^1–3 Despite these desirable results, however, VCDs are used in 20–25% of all catheter-based procedures performed worldwide.^4–5 The reason for this gap has historically been attributed to two major issues: cost considerations and the lack of level-I data proving a clinically relevant reduction in access-site major vascular complications (MVCs) compared to the gold-standard practice of manual compression. Another important, yet relatively underrated, factor that may explain this discrepancy is that the original VCD studies had remarkably long lists of exclusions, which in turn limited the pool of potential recipients. Optimal underlying anatomy, seamless healthy average-sized vessels and perfect sheath insertion site, among others, were prerequisite before a closure device was even considered in the catheterization laboratory. This likely hindered the external generalizability of reported trials which was reflected by slower penetration in the endovascular community.
In this issue of the Journal, Rashid and colleagues present the results of a single-center, prospective, off-label registry utilizing the second-generation, extravascular, metallic clip-based Starclose™ (Abbott Vascular, Santa Clara, California) VCD in 98 patients undergoing diagnostic coronary angiography.⁶ This registry is unique in that it tested the use of this device in participants who had at least one reason to either contraindicate or recommend against the use of Starclose based on the device’s instruction manual. Approximately one-third of participants had more than one inclusion criterion, with 30% qualifying based on the presence of angiographically confirmed femoral artery stenosis, 24% had femoral arterial calcification and 46% had a non-common femoral sheath insertion. Importantly, subjects who underwent intracoronary instrumentation (intravascular ultrasound, percutaneous coronary intervention, etc.) and/or intraprocedural anticoagulation were excluded and a notable 18% of participants were markedly obese (body mass index > 35%).
Despite this higher-than-usual risk for access site complications, the Starclose device performed well, allowing for 100% procedural success (final hemostasis achieved without MVCs) and 94% device success (immediate [< 5 minutes] hemostasis achieved without MVCs). Remarkably, none of the 5 subjects with device failure suffered a MVC and they were all successfully managed with manual compression for less than 30 minutes. This suggests that Starclose failure did not necessarily lead to vascular catastrophe in study participants in spite of their high-risk characteristics for MVCs. Moreover, when compared to the historic controls in the diagnostic arm of the pivotal CLIP trial, an unexpected statistically significant reduction in the average time to ambulation (from 162.9 ± 104.6 to 78.1 ± 47.3 minutes [p < 0.001]) was evident.⁷ The lack of adverse events in the 18 markedly obese participants is also surprising. These results led the authors to conclude that the Starclose VCD was safe and effective for early ambulation in high-risk patient subsets with an increased risk of bleeding or non-ideal common femoral artery anatomy.
We congratulate the authors for their novel study and believe they have made an important contribution. Several issues, however, need to be addressed before generalizing the results of this report to the exceedingly heterogeneous population of endovascular patients with contraindications for traditional VCDs. First, as correctly stated by the authors, the study design is an important limitation. This single-arm registry compared selected endpoints to a rather divergent group of historic controls from the CLIP trial. Such a design does not allow for firm conclusions related to a preferential device performance in a particular population. Furthermore, the lack of an active comparator arm (manual compression, another VCD), the relatively high (> 6) screened-to-enrolled ratio, the requirement for experienced operators who had long graduated from their early learning curves (must each have successfully performed ≥ 25 Starclose deployments), and the use of 6 Fr arterial sheaths in all patients at a time when many laboratories are using 5- or 4-Fr sheaths for diagnostic cardiac catheterization, further limit the external generalizability. Interestingly, patients who qualified based on stenotic indications were enrolled because of the presence of mild-to-moderate (30–70%) femoral artery stenosis. On final quantitative angiographic analysis, however, the average luminal stenosis was 35.3 ± 5.1%, indicating that most patients had mild, rather than moderate or significant, peripheral arterial disease.
Although the issue of immediate or future local and systemic inflammation caused by VCDs continues to be investigated, recent data suggest that closure devices that actively approximate the arteriotomy edges, leaving behind an intraluminal foreign body such as the Angio-Seal (St. Jude Medical, St. Paul, Minnesota), which leaves a permanent anchor and collagen sponge, and the Perclose (Abbott Vascular, Abbott Park, Illinois), which leaves behind a nonabsorbable suture, did not trigger a more intense systemic inflammatory response following diagnostic coronary angiography than that seen with closure technologies that employed passive mechanical compression (FemoStop^®, Radi Medical Systems, Inc., Reading, Massachusetts).⁸ On the other hand, histologic data in a canine model demonstrated more extensive extravascular and periadventitial scarring with the use of AngioSeal device compared with the Perclose device at 4 weeks post femoral artery closure. It is intuitive to presume that such local changes are likely most prominent in thrombin-based, suture-based and collagen-based intravascular devices compared with extravascular devices. The Starclose is an extravascular closure device with tines designed to deploy in the vessel wall media. It remains unclear whether the reaction between the external layers of the arterial wall and the surrounding soft tissue on one side and the nonabsorbable nitinol clip would provoke exaggerated inflammation or scar formation that may potentially prohibit future use of VCDs (both endo- and extravascular). Likewise, the safety and efficacy of using this device in individuals with access site scar tissue caused by accessing the site previously, even in the absence of prior use of a VCD, has been questioned.⁹ These are particularly important issues to consider given the frequent need for repeat endovascular procedures in these patients. The arrival of extravascular VCD designs that provide totally absorbable sealants has energized the endovascular community about this technology.¹⁰ Whether these will eliminate such concerns and bring us a step closer to the optimal VCD remains largely unknown, but certainly merits further testing. Finally, we share the authors’ initiative that there is a need for rapid and safe management of the femoral access site in subgroups deemed high-risk for serious complications. Thus, we agree that it is time for large-scale studies to evaluate the use of closure devices in these populations.

References

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